COVID-19

The worldwide rush demanded by the pandemic to develop and/or identify a potential treatment or vaccine has culminated in remarkable success in expediting COVID-19 trials, and the lessons learned are likely to be applied even after the pandemic is over. Read More

Just two years after releasing a major revision of its good clinical practice (GCP) guideline, the International Council on Harmonization (ICH) is planning a new update that would require additional adjustments from sponsors and sites that still may be trying to catch up with the first revision. Surprisingly, the COVID-19 pandemic could end up making that task easier. Read More

The European Commission and European Medicines Agency (EMA) as well as the Heads of Medicines Agencies (HMA) have added new recommendations on distribution, monitoring, remote source data verification (SDV) and communication with authorities to their guidance on managing trials during COVID-19. Read More

The International Coalition of Medicines Regulatory Authorities (ICMRA) has released new recommendations to ensure efficient regulatory processes that will support the development of diagnostics and treatments for COVID-19. Read More

As pharma companies report on first-quarter earnings, most appear hopeful that they can limit the impact of the pandemic on their current trials and return to near-normal conditions by the end of the year. Here’s a sampling of what happened last week: Read More

While the FDA strictly enforces the handling of investigational drugs, the COVID-19 pandemic is shining a spotlight on the accountability issues involved. Agency regulations are only two paragraphs long, giving investigators and sponsors little guidance on the specifics of the drug management process. In the absence of clear instruction from the FDA and other regulators, the clinical trials industry has begun to develop its own standards. Read More

The upheaval in trials caused by the COVID-19 pandemic should result in an increased number of options for trial participants, greater support for increasingly complex trial protocol designs and more collaboration among sponsors. Read More

As the medical community shifts much of its focus — and its resources — to battling the ongoing COVID-19 pandemic, clinical trial sponsors and sites are left wondering what to do about ongoing drug and device studies unrelated to the coronavirus. Which studies should be paused and which should be allowed to continue? Could modifications to study protocols around data collection and patient visits strike a balance between maintaining both patient safety and the integrity of ongoing trials? Read More